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Posted:3 weeks ago| Platform: Linkedin logo

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Skills Required

documentation risk assessment traceability reports qc compliance data integrity software audit controls management support integration lims audits training

Work Mode

On-site

Job Type

Full Time

Job Description

  • Prepare and review validation documentation (URS, Risk Assessment, IQ/OQ/PQ protocols, traceability matrix, validation reports) for computerized systems used in QC.
  • Ensure compliance of QC systems with applicable regulatory and data integrity requirements.
  • Collaborate with QC Analyst, IT, QA, and equipment / software vendors for implementation and validation of instruments and associated software (e.g., HPLC, GC, UV. Dissolution systems).
  • Coordinate periodic review of validation systems, including assessment of audit trails and system access controls.
  • Maintain validation state of systems through change control, deviation management, and revalidation activities.
  • Support in qualification of new laboratory instruments and their integration with LIMS or standalone use.
  • Assist during regulatory audits and inspections related to data integrity and system validation.
  • Provide training and awareness to QC Staff on validation systems and data integrity practices.

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Alkem Laboratories Ltd.

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